LBK 1244 DELFIA HCG KIT— 510(k) K852760

Substantially Equivalent

Lkb Instruments, Inc.

FDA 510(k) clearance K852760 for LBK 1244 DELFIA HCG KIT, Substantially Equivalent on 1985-12-05. Applicant: Lkb Instruments, Inc..

Clearance details

Applicant: Lkb Instruments, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1985-06-28
Decision date: 1985-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.